CSPI Urges FDA to Seize Stockpiles of Bayer One A Day for Men

New Evidence Undermines Bayer’s Prostate Health Claims

June 29, 2009

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For most men with prostate cancer, the dietary supplement selenium may promote more aggressive cases of the disease, according to a new study. Besides being bad news for men who have taken selenium in the hope of avoiding prostate cancer, the study comes at an inconvenient time for Bayer Healthcare, which was notified recently that it will be sued if it continues to claim that the selenium in its One A Day vitamins for men reduces risk of the disease or otherwise benefits the prostate.

Today, the Center for Science in the Public Interest filed a formal complaint with the Food and Drug Administration over the various prostate claims on One A Day's labeling. The claim that the selenium in One A Day Men's Health Formula reduces the risk of prostate cancer gives the product the status of an unapproved drug, and is therefore illegal. Even the more general claim Bayer uses to promote that and another men's supplement that selenium "supports prostate health" is deceptive and illegal since it is unsubstantiated by scientific evidence and implies that the product can reduce the risk of prostate cancer. No published studies have investigated whether selenium helps or hurts when it comes to the only other common prostate problem, benign prostatic hyperplasia, or enlarged prostate. CSPI says the FDA should seize existing stockpiles of the deceptively labeled products until the company corrects the labels.

Coincidentally, on June 19, the FDA authorized a very negatively worded "qualified health claim" which Bayer is unlikely to use, according to CSPI. It reads:

Two weak studies suggest that selenium intake may reduce the risk of prostate cancer. However, four stronger studies and three weak studies showed no reduction in risk. Based on these studies, FDA concludes that it is highly unlikely that selenium supplements reduce the risk of prostate cancer.

Even if Bayer wanted to use that new claim, it could not since it only applies to a certain form of selenium, selenomethionine. Bayer uses the selenate form of the mineral in One A Day pills.

To prevent consumers from being misled, CSPI said that FDA must halt not only the claim that selenium reduces the risk of cancer, but also the milder claim about supporting prostate health. CSPI says that "supports prostate health" is deceptive because there's no good evidence to support it.

On June 18, besides notifying Bayer of a potential lawsuit, CSPI filed a complaint with the Federal Trade Commission over Bayer's advertising. Some of the leading prostate cancer researchers in the country wrote the FTC in support of CSPI's complaint. Bayer has yet to respond to CSPI's demand letter, but news reports indicate that the company may already be retreating from claiming selenium reduces risk of prostate cancer, but has not promised to remove the more generally deceptive claims concerning "prostate health."

In the latest study, published in the Journal of Clinical Oncology, researchers at the University of California at San Francisco looked at men with localized or locally advanced prostate cancer, and found more aggressive cases of cancer in men with high selenium blood levels and the V genotype for an antioxidant enzyme found in most cells. Seventy-five percent of men have the V genotype; only 25 percent of men have the AA genotype which seems to reduce their risk of aggressive prostate cancer. The findings "indicate caution against broad use of selenium supplementation for men with prostate cancer," the authors wrote.

Yet another study, this one published this month in the journal Circulation: Cardiovascular Quality and Outcomes, found that men with higher blood selenium levels were more likely to have hypertension than men with lower blood selenium levels.

The most ambitious examination ever conducted to see if selenium prevents prostate cancer, the Selenium and Vitamin E Cancer Prevention Trial (SELECT), was actually halted early when researchers discovered that besides not preventing prostate cancer, selenium supplements might have been causing diabetes in the men assigned to take it.

"Bayer must be stopped from promoting its selenium-containing products as a means of reducing prostate cancer risk and promoting prostate health," said CSPI senior nutritionist David Schardt. "Not only does selenium not prevent cancer, supplementation with selenium may be harmful."

Bayer is a repeat offender when it comes to misleading claims on labeling and advertising, according to CSPI. In 2007, it paid a $3.2 million fine as part of a consent decree reached with the Federal Trade Commission and the Department of Justice over weight-loss claims made in connection with another One A Day product. Bayer is also running a $20-million corrective advertising campaign about its birth control pill Yaz at the behest of the FDA and a number of state attorneys general.

"By violating the terms of the FTC consent decree, Bayer could be held in contempt of court," said CSPI litigation director Steve Gardner. "The FTC should penalize Bayer substantially, and require corrective advertising. In addition, the FDA should coordinate with the FTC to stop all claims that fall within its jurisdiction."

In separate letters, today, the CSPI urged Major League Baseball and the Prostate Cancer Foundation to stop lending their names to a promotional campaign for Bayer One A Day. Bayer and MLB jointly contribute $10 to the foundation for every strikeout thrown by a major league pitcher. The amount of money that the charity stands to gain in a typical season, then, would be in the $350,000 ballpark, in all likelihood a small fraction of the profits that Bayer rakes in from the deceptive labeling and advertising.